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User Manual

Bagmatic NOVO LS
Version 1.0
May 2017

Valid for SW version


From 2.00.00

Lmb Technologie GmbH


Möslstraße 17
D-85445 Schwaig

Tel: +49 - 8122 - 880 96 - 0


Fax: +49 - 8122 - 880 96 - 60

www.lmb.de
info@lmb.de
User Manual - Bagmatic NOVO LS

PREFACE

About this document

This user manual contains the technical specification of Bagmatic Novo LS and all
the necessary information and support for the operator. In order to achieve the
optimal result we recommend that the user reads this document carefully before
any operation with the product.

The information in this document is subject to change without prior notice in order
to improve reliability, design and function and does not represent a commitment
on the part of the manufacturer.

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Contents

1 GENERAL PURPOSE............................................................................ 6
2 INTENDED USE .................................................................................. 6
3 WARRANTY ........................................................................................ 7
4 SAFETY ADVICES ............................................................................... 8
4.1 General safety advices ................................................................... 8
4.2 Description for proper workspace .................................................. 9
4.3 Warning notes regarding incorrect use .......................................... 9
4.3.1 Device damage............................................................................... 9
4.3.2 Risk to user .................................................................................. 10
4.3.3 Quality Problems.......................................................................... 10
4.3.4 Blood preservation damage ......................................................... 10
4.4 Installation details ....................................................................... 10
4.5 Remaining risks ........................................................................... 11
4.6 Restriction to guarantee secureness in occasions ........................ 11
4.6.1 Installation secureness ................................................................ 11
4.6.2 De-installation secureness ............................................................ 11
4.6.3 Shut-off condition secureness ....................................................... 11
4.6.4 Out-of-order condition secureness ................................................ 11
4.6.5 Maintenance and Service secureness............................................. 11
4.6.6 Transportation secureness .......................................................... 12
4.7 Safety instructions for transport and storage .............................. 12
4.8 Procedure recommended in case of emergency or casualty ......... 12
4.9 Safety measures for installation and maintenance....................... 13
5 GENERAL INSTRUCTIONS ................................................................ 13
5.1 Service interval ............................................................................ 13
5.2 Cleaning instructions ................................................................... 13
6 WHAT YOU HAVE ............................................................................. 14
7 TECHNICAL DATA ............................................................................ 15
8 OPERATING WITH BAGMATIC NOVO LS ........................................... 17
8.1 Screen explanation ...................................................................... 17
8.2 Menus explanation ....................................................................... 19
8.3 Donation Process ......................................................................... 21
8.4 Balance check and calibration procedure ..................................... 27
8.5 Connect and work with Barcode reader ....................................... 30
8.6 Barcode comparison..................................................................... 30
8.7 Barcode order .............................................................................. 31
8.8 Barcode timer .............................................................................. 31
8.9 Usage of Bagmatic Novo LSas "Bar Code collection point" ........... 31
8.10 Bi-direction .................................................................................. 31
9 BATTERY.......................................................................................... 32
10 BAGMATIC NOVO LS SYSTEM ........................................................... 36
10.1 Erysys Start-up and adjustment ................................................... 39
10.2 BN_Setup Tool ............................................................................. 43
10.3 BN_Live ....................................................................................... 48
10.4 BN_Data Center ........................................................................... 49

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11 RF RANGE LIMITATIONS ................................................................. 53


12 MAINTENANCE................................................................................. 54
12.1 Maintenance schedule .................................................................. 54
12.2 Periodic Preventive maintenance ................................................... 55
13 TROUBLESHOOTING ........................................................................ 56
13.1 Balance failed .............................................................................. 56
13.2 Battery error ................................................................................ 56
13.3 RTC error ..................................................................................... 56
13.4 Clamp error .................................................................................. 57
13.5 EEPROM ....................................................................................... 57
13.6 Wrong weight on tray and missing tube in the clamp .................. 57
13.7 Over weight error ........................................................................ 58
13.8 Pause ........................................................................................... 58
13.9 Stop ............................................................................................. 59
14 EXPLANATION OF SYMBOLS ............................................................ 59
15 SPARE PARTS .................................................................................. 60
16 ALERT LIST ...................................................................................... 62

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1 General Purpose

Congratulations! You purchased one of the highly advanced blood taking


monitor devices. It is the result of intense research and development.
We, Lmb, guarantee for the highest quality in development,
manufacturing and service of this product.

This manual describes the optimal way how to operate this device and
gives basic instructions for handling, possible errors or operation failures.

Before you start using the Bagmatic Novo LS please read this manual
carefully to avoid mistakes.

2 Intended use

Blood taking monitor Bagmatic Novo LS is used to monitor blood


collection during donation process. Movable bag tray is designed to
accept any type of the bags independent from producer.

Bagmatic Novo LS have easy access and clearly understandable touch


screen menu with user friendly interface.

Bagmatic Novo LS is designed for both mobile and stationary use. In


case of mobile use and transportation of Bagmatic NOVO LS, it is
necessary to use appropriate compact transport case. Device registers
the blood flow velocity, mixes the collected blood with the blood
stabilizer by constant 3D shaking of the collection bag, records
interruptions or failures and is used to control the previously defined
sampling volume. Bagmatic Novo LS can collect and transfer various
important donation data, explained in details in section 10 of this user
manual.

Device should be used only by trained nurses, doctors or phlebotomists.

Bagmatic Novo LS monitors the whole donation process according to the


medical requirements and after expiration of the donation process the
extraction is finished automatically when the selected donor’s final
volume is achieved. Results of donations should always be according to

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design tolerances. Also should be very easy to change profile of


donations, in terms of changes in blood collected volume.
According to all operations, there is no direct contact with patients, i.e.
blood donors. Speaking of indications for use and contraindications, there
are no any undesired side effects of device.

3 Warranty

All units are produced and checked with the most care by the
manufacturer. However, should a unit show a malfunction, we give each
Bagmatic Novo LS a warranty period of twelve months from date of sale.
Warranty is valid only if the user complies with the following rules:

 Defective Bagmatic Novo LS must be sent to LMB or to the


nearest authorized service facility in the original packaging only.
Damages to units sent without original packaging will not be
covered by warranty.

 The purchase invoice should be included, along with a detailed


description of the defect.

Damages resulting from operating errors, misuse, manipulation,


carelessness, or any intervention unauthorized by LMB are not
subject to warranty. LMB can grant a perfect operation only if
Bagmatic Novo LS is used with the original power supplier
specifically designed for this instrument.

 Warranty does not include the rechargeable batteries and the
necessary labour for their replacement because they are
considered consumable parts.

For further information concerning warranty please contact LMB


Technologie GmbH.

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4 Safety advices

4.1 General safety advices

For safe handling with the Bagmatic Novo LS device,

Pay attention! Please avoid in any case below:

 To connect the bar code reader during operation of the Bagmatic


NOVO
 To let the bar code reader connected with the cable during the data
selection! This might destroy the exit.
 Dangers- of mechanic kind or caused by electric power- have not to
be feared if the device is used properly. In the following we give you
notes for the save use of the device.
 Dangers caused mechanically or electrically don’t need to be feared if
you operate in an appropriate way.
 According to that, we give you some instructions for the safe
operation of the device:
 The product must be used only by trained personnel.
 In the case of injuries due to inappropriate handling or operation,
any liability and guarantee claim will expire.
 Please use only the delivered battery charger. For further information
read chapter about delivery content and technical data
 Mechanical dangers can appear at the moving tube clamp device and
at the tilting mechanism. That’s why you should never grasp into the
moving mechanical parts.
 Please follow also the instructions written on the unit itself.
 Connect only devices and accessories to the ports of the BAGMATIC
NOVO LS that fulfil the regulations of SELV-circuits.
 The unit is not responsible for the sealing and welding of the blood
bag tube. We explicitly point out that the demanded medical
protection for closing or clamping the blood bag tube fall under the
responsibility of the unit that is responsible for this special action.
 Avoid constant extreme humidity and condensation. Avoid that fluids
reach the interior of the device.

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 Don’t try to repair the electrical and mechanical systems on your


own. Only instructed technicians are allowed to open the device. For
this purpose please contact the service of Lmb (technical-
service@lmb.de).

4.2 Description for proper workspace

The workspace need to be according to standards for blood transfusion


centres and environmental recommendations by domestic health care
administration.

Put the device in a suitable position. Make sure that it is placed


horizontally. Make sure that the place of the device is not directly
exposed to sunlight or any other high intensity source of light. Also, this
place must not be under influence of vibration, high temperature and
humidity.

The user should have access from front side and from left and right for
best access to the device. The device is designed for transportable use
and can be placed directly on the transportation case.

The user should have always best view to the display as well. The user
approach to the device needs to be always from up front. The user needs
to be able to interfere and to check and react on all occasions and
processes.

4.3 Warning notes regarding incorrect use

Different use as intended and described in this manual may lead into
problems listed below:

4.3.1 Device damage

- Caused by drop of the device lead into serious damage of electronic


balance, mechanical and inner components. The device can resist
shock only as long it is well packed in its transportation case.

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4.3.2 Risk to user

- Caused by incorrect use of the device. The device is able of being


checked and activated beside the intended use. In such case it is
possible, if you are careless, to clamp hand and fingers by activating
the clamp-swing-mechanism. The operator must be aware that beside
the taken precautions of clamp force limitation that hand and fingers
can be pressed strongly when put into the moving parts.

4.3.3 Quality Problems

- Caused by incorrect settings or wrong programs selected by mistake


or improper prepared blood bags. Besides the taken precautions of
limited access to the device and procedure parameters a mess-up of
settings is always possible. That can have very bad influence of the
quality and quantity of the estimated results of blood donation. The
operator must be aware that consequences.

4.3.4 Blood preservation damage

- Caused by incorrect blood bag handling. The device cannot check


condition of the blood preservations itself. All blood units will be
handled as fully intact and properly prepared. Damaged blood bags or
tubes will stay unnoticed. The operator must check the blood bag
conditions and result of preparation always. Any damage on the bag
or incorrect placement can lead in total destruction of the bag and
loss of the product with all effects of blood contamination. The
product must be disposed then.

4.4 Installation details

All details are stated in service manual; only authorized technician can
do installation! The installation can only be done by trained personnel
with full application training received from Lmb and its partners.
Special requirements of the operating personnel are not necessary.

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4.5 Remaining risks

The Lmb Company has taken care in production and design to eliminate
all risk potential. Some possible risks remain because of exposed items
such as balance parts and the clamp mechanism. The balance parts and
clamp are highly necessary for the function.

4.6 Restriction to guarantee secureness in occasions

4.6.1 Installation secureness

The device must not be installed to other power sources and as described
on the S/N Label placed behind of device.

4.6.2 De-installation secureness

The device can be unplugged from power and switched off and battery
can be ejected after freeing of the device (remove bags etc.).

4.6.3 Battery life secureness

The device automatically switches off to sleep mode if unused for defined
set time (until button is pressed again or the weight is detected on
balance tray).

4.6.4 Out-of-order condition secureness

If the device is declared to be out of order and prohibited for use than
unit need to be shut down by switching off and replaceable battery must
be ejected and the charger has to be unplugged.

4.6.5 Maintenance and Service secureness

The special service (maintenance) menu allows to use and to maintain


the device in full operation mode and when power is present. Only
service personal authorized by Lmb and its partners is allowed to do so.

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Users need to be informed about current device status and in case


instructed by the service technician in charge.

4.6.6 Transportation secureness

Special care during transport is necessary. Take the balance tray and
accessories away before lifting. Do never carry the device on the balance
plate. Lift and transport the device only with 2 hands or in the
appropriate transportation case.

4.7 Safety instructions for transport and storage

The device weight is 3.65 Kg, plus additional weight for other
accessories, check section 7. Technical for details. Transportation has to
be done in proper box secured against shock and moisture. The balance
tray can be placed upside down on top of the device. The device should
be stored in controlled environment. To guaranty full functionality of the
device over longer period of storage the room temperature must in
between 10°C–40°C and the replaceable batteries should be removed. In
case of higher or lower temperature during transport the device need to
be brought to standard environmental area 20 min before use because of
possible condensing on device.

4.8 Procedure recommended in case of emergency or


casualty

According to the most SOP for blood transfusion centers, in case of any
emergency or malfunction, the device need to be declared as out-of-
order and taken out of operation until status of device is going to be
changed by higher authorization. Service contractor or Lmb partner need
to be informed about the device conditions and about condition of last
processed blood unit and result.

It is highly advisable to notify all seen problems and occasions and to


share this information with next person in charge and the service
technician. That cooperation can help to identify the problematic and to
have the unit as quick as possible back in operation.

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4.9 Safety measures for installation and maintenance

 Please use only the delivered charger and power supply


 Connect only accessories tested from Lmb
 Avoid constant extreme humidity and condensation.
 Protect the device from water and chemicals.
 Only instructed technicians are allowed to open the device.

General Instructions

The BAGMATIC NOVO LS is a blood taking monitor. The weight recorded


by the BAGMATIC NOVO LS doesn’t meet the calibration standards of the
EU directive 90/384/EWG. For more exact weight results you should use
a scale meeting the requirements of these calibration standards.

The device cannot be used for “invitro” or “invivo” analysis purposes.

4.10 Service interval

Recommended maintenance time is after one Year. Calibrations and full


working check, testing, should be done once a year, see Maintenance
schedule, section 12.

4.11 Cleaning instructions

For cleaning of parts of the housing and all other parts that are
accessible from outside, please use an alcoholic area-wide disinfectant as
it is used in clinics. For harmless contamination even spirit can be
utilised. Can be clean and decontaminate with Sodium hypochlorite 9%
Chlorine, mild detergent, ammonium quaternary, aldehydes, 75%
isopropyl alcohol.

Device can easily be cleaned from dust, spilled or leaked blood or blood
components. Frequent cleaning will offer users the best long-term
results, see Maintenance schedule, section 12.
For proper cleaning, use a dry cloth or a cloth dampened with water. A
cleaning alcoholic agent may be used. Do not use paint thinner, benzene,
solvent or any strong detergent.
Follow the decontamination procedure of your facility when a blood spill
occurs.
Avoid spraying liquids on the clamping head.
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Refer to the procedures below:

(1) Turn off the device.


(2) Remove the balance tray and clean it separately.
(3) Clean clamping head using cotton swab and mild detergent solution.
(4) Put the balance tray on.
(5) If you have used water, detergent or decontamination liquid, wait for
a few minutes to allow for thorough drying.
(6) Turn on the device and test it.

5 What you have

Bagmatic Novo LS Basic Version

- Blood donation monitor – 3d Mixing standard version


- User manual
- Power/Battery charger adapter
- USB communication module
- BNC basic communication SW

Bagmatic Novo LS Full Version

- Blood donation monitor – 3D Mixing Standard Version


- USB communication module
- Li-Ion Battery (option)
- Power/Battery charger adapter
- External battery charger (single or multi for 6 batteries) (option)
- Lmb USB RF Module – on the PC side (option)
- Bagmatic Novo LS RF Module (option)
- Erysys Software license(option)
- User manual
- Barcode reader(option)
- Barcode holder(option)
- Tube holder for 10 tubes(option)
- 500g weight (option)
- Transportation case against shocks and falls, used as support for
mobile and in-house donations (with possibility to store all
accessories) (option)

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6 Technical Data

Technical data- Bagmatic NOVO LS


Stand by (battery mode) <2 W
Working mode < 8W
Power Consumption
Max (working while charging)<25 W

Communication - standard USB cable


Wireless communication module RF-RC232, Rx -97dBm, f:868-870MHz
(range in free space) - optional Max Range: ≤55m
TFT 480x272 DOTS, 16-BIT (65,536)
Display
COLORS
Display dimension 95x54 mm
3D system speed 12-14 rpm
Clamp Time 2 sec
Donation storage capacity max 5000 donations
Data transfer duration <5sec per donation
Barcode support Code 128, Code 93, Code 39
Weighting range 1-999 ml/gr
Accuracy ±1.5%
Battery 14.4V, Li-Ion smart, 3.1 Ah or 3.4 Ah
Battery charger (Single) Input: 110-240VAC, 50-60Hz,
Battery charger (Multi 6x) Output: 24VDC, 2.5A
Single charge donation count 50 or up to 8hrs of work
Fuse 0.8A/250v/T
Storage and transport
-20÷+50°C, 20÷90% non-cond.
conditions
Working conditions +10÷+40°C, 20÷90% non-cond.
Weights
Device without battery 3.65kg
Mobile accessories
Power supply 0.38kg
Battery 0.23kg
Transportation case with sponge 5.2kg
Tube holder for 10 tubes 0.1kg
Barcode holder 0.13kg
Barcode 0.17kg
Device Plexiglas plate 0.8kg
Total weight ≈11kg
Device dimensions with Bag tray 320 x 240 x 215 mm (L x W x H)
Transportation case dimensions 500 x 300 x 365 mm (L x W x H)

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Input: 110-240VAC, 50-60Hz,


Power supply specifications
Output: 19VDC, 4.74A, 90W

Compliance data

Classification Medical device class IIa


MDD 93/42/EEC
Directive and Standards applied EN 60601-1; EN 60601-1-2 ; EN 62304;
RoHS2
Classification (Protection against
Class II, Type B
electric shock)
Specifications may vary depending on customer request.

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7 Operating with Bagmatic NOVO LS

In the beginning of operation and during work with the Bagmatic NOVO
LS, please observe the security instructions in chapter 4 of this manual.

7.1 Screen explanation

Turning device ON

Press and hold button on the left bottom side until device switch ON, and
power diode is ON.

Power ON

First message is information message to “Remove everything from tray”.


After removing please continue to self- test by OK button confirmation.

Wait until self-test is finished and that device changes from LMB logo to
main screen, which will indicate that device is Turned ON and ready to
use.

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Important:
Not following above mentioned instruction may lead to
measurement error.

Main Menu screen

If the bag tray is not in its initial position device will automatically adjust
it. During initialisation process device will test important hardware
modules. If self-test passes all the tests, Main Menu will appear.
If there is any kind of error during self-test, it will be displayed on the
screen. Check Troubleshooting section.

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Turning device OFF

Press in upper right corner of the screen, press button like on the picture
below.

Power OFF button

This will initiate the message if you are sure that you want to Turn OFF.
After confirmation on Yes, device will shut down and power diode will go
OFF.

Turn OFF message

7.2 Menus explanation

MAIN MENU

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Main menu consists of 6 selectable options, DONATION,


DONATION PROFILE, BALANCE, LAST DONATION, SETUP, SHUT
DOWN. Browsing through the menu is done by finger touch. Information
for battery status, time and date is visible on the screen below Donation
button.

Setup menu is password protected and should be only used by skilled


and trained personnel (for more details about these menus please refer
to the service manual).

DONATION PROFILE
Donation profile selection is performed in Donation profile menu.
There are 6 available profiles which are possible to select by standard
operator, with additional 6 new profiles on second page (possible to add
by Bagmatic Novo LS software). Change and edit is possible only by
authorised Supervisor operator in password protected Setup Menu.

Available profile selection


If you like to EDIT profile, it is possible to change following profile
parameters:
Collected Volume, Nominal Duration time, Maximum Duration
time, Number of bags, Number of tubes.
Possibility to have special profiles for recording only tube codes.

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BALANCE Selection
Shows the total weight in grams placed on the balance.

Weight measured on balance


In case measured value is not correct, and balance is not giving precise
weight, it is possible to initiate Balance check procedure by selecting
button on the top of the screen. See details and description in section
8.4.

7.3 Donation Process

1. In the main menu choose the first option DONATION with a


finger touch.

Donation start button

Profile which is currently active is possible to see inside a button area (in
example above, Profile 1 is 450ml). In case it is needed to be changed,
select new profile from DONATION PROFILE MENU.

2. Change Profile from default value, is also possible by touching


profile name in the next menu which appears.

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Place bag and insert tube

3. Place bag and the tube in to the clamp. Put the bag (bag system)
onto the blood bag tray and lead the connection tube ‘through’
the clamp. Tube should be placed in the clamp in that way, that
the length of the tubing from clamp to bag is approximately 15-
20cm. Then Press OK.

In case you do not put the tube inside of the clamp, Bagmatic will
notify that clamp is missing and will not let you continue further
until you properly insert the tubes. Automatic detection of missing
blood bag and Tara of the blood bag system will be performed in
this step. In case of missing blood bag system, operator will be
informed by screen message.
Above menu will not be showed if the tube and the bag is properly
placed before pressing Donation button on the Main screen, and in
case it is only one of this two mandatory steps performed, there
will be notification only about one which is missing.

4. If tube is detected correctly, clamp will close and ATTACH


DONOR message will be on the screen. Press OK after attaching

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donor to continue. In this Menu it is possible to change Profile in


case it is needed by touching the Profile name.

Attach donor
5. Donation status and progress

50% Donation progress


Screen information during donation

a) Selected profile, picture above example Profile 1:480ml


b) Duration time, example 03:17min
c) Current blood flow in ml/min, example 67ml/min
d) Current weight collected in gr or ml, example 240ml as 50% of
total Donation progress

When blood donation starts, clamp will open to release the blood
flow through the tube into the bag. Bag tray will not start shaking
until some volume is detected on the balance, by default setup it
is 10ml. After 10ml reached, 3D movement of the mechanism will
start.

During Donation process it is possible to Pause the Donation for


user defined period in case of labelling, and continue afterwards
manual or automatic, or to STOP the donation and finish current
donation.

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Possible error codes during donation process

a) Start weight on bag tray is not within normal range (20-800


gr/ml)
b) Operator STOP
c) Interrupt (pause) time exceeded
d) Exceeded maximum weight on bag tray during donation

When collected blood volume reaches 90% of wanted volume device will
signal it with one beep and green flashing light. If there was any kind of
error, light will be red.
During collection it is possible to use 4 different predefined speeds for
continuous mixing of the blood bag.

6. End of Donation
At the end of the donation process, clamp will close and all the
important parameters and values will be shown on the screen.

End of Donation

7. Detaching the donor, final step for ending donation.


Detach the donor only when this message appears, it means that
tube is clamped and it is safe to remove the needle from the
donor. To confirm that detach is finished and open the clamp
press OK.

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Detach donor

Possibility to maintain mixing after end of donation can be turned ON by


changing donation parameter responsible for it.
8. Live view of donated blood weight and donation information
On the end of donation last screen message will display current
weight/volume collected with additional donation information
which have been explained above. To finalize donation press OK.

Live view

Live view is possible to have in ml/gr/or both, depending on a setup


parameter.

Pressing OK button at this moment will send the data to server


and end the donation process. If there is no possibility to send
the data to server device will store the data on data memory.

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9. Barcode scanning
In case barcode are selected to be scanned, device will ask
different barcodes on a different time during donation according
to setup. Setup can be performed by trained personal.
Bagmatic Novo LS will notify and guide the user to scan any of
above showed barcodes which are set.

Barcode reading dialog

Barcodes can be scanned in order as showed on the below


picture.

Barcode setup

Barcodes which can be selected to be scanned are showed in


Section 10.

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7.4 Balance check and calibration procedure

Balance check procedure


Because of mobile intended use of the device, Bagmatic Novo LS is
equipped with a smart system to check if balance is in adequate
tolerances accuracy. Tolerance range is possible to modify by parameter
in setup and also to switch it OFF.
By default “Balance check” is turned ON every day, and device will
require it on the beginning of every new day during first start of the
device in following sequence:
a) During Turning ON device will prompt message to remove
everything from start.

Clear the tray

b) When dialog as below appears add 500g weight on the tray,


wait 5 second to stabilize the weight and press OK.

500g weight

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c) Confirmation screen leading you afterwards to finalize balance


check process

Balance check successful


In case Balance check procedure is not finished successfully, device will
ask you to perform Balance calibration.

Balance calibration procedure

Balance calibration is performed by trained Supervisor operator and it


requires to enter Calibration password. Calibration password will be given
to trained Supervisor operator by Lmb Technologie or Distributor.

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a) Remove everything from the bag tray, and press OK button

Clear the tray

b) When dialog as below appears add 500g weight on the tray,


wait 5 second to stabilize the weight and press continue (OK).

500g weight

c) Confirmation screen leading you afterwards to finalize balance


check process

Balance check successful

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7.5 Connect and work with Barcode reader

If the device is still running, turn it OFF.

Unpack barcode reader and connect the 3-pin-connector to the scanner


port on the back of Bagmatic NOVO LS.

All settings regarding barcodes can be changed by using Erysys software


and only authorized person can change default parameters. If the
barcode scanning is turned on it will slightly change donation procedure
depending on type of barcode and the time of scanning (at start, end of
during the donation process).

7.6 Barcode comparison

To prevent user from wrong labeling of the bag or tubes donation


barcode and all of scanned tube barcodes must be the same. When
scanning device will compare the barcodes and inform user if there is
any error. Donation number, Donor code and Tube code barcodes must
be turned on and setup in exactly that order.

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7.7 Barcode order

For easier organizing of the donation process it is possible to arrange the


order of scanned barcodes by end user requirements using ERYSYS
software.

7.8 Barcode timer

Barcodes must be scanned in 90 seconds or the device will inform the


operator about this error with 1 beep sound every second and flashing
red light.

7.9 Usage of Bagmatic Novo LS as "Bar Code collection


point"

Procedure for tubes collection, for following new donor is next:


- Start donation process
- Scan tube bar code for new donor
- Cancel donation procedure
All scanned bar codes will be stored on internal memory and later can be
transfer via wireless or cable connection.

7.10 Bi-direction

To enable this function it is necessary to check BIDIRECTION


option in PROC.CONFIG menu.
Donation process starts with reading the donor barcode. If read
barcode exists on the server, device will collect the data from database
and start with donation process using this data.
If there is no information about, scanned donor device will inform
the operator about this error.
If ALLOW DONATION option is turned on, operator can start
donation process with parameters set in current profile.

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8 Battery

Device is equipped with powerful smart system battery, positioned is on the


back side of the device. Battery itself have capacity indication of the
housing and operator can notice easily if battery needs to be charged.
Housing and battery design ensures simple plugging and unplugging
procedure. Battery is not possible to mount in a wrong position.

Battery position

Battery indicator

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General Precautions

Handling
•Avoid shorting the battery
•Do not immerse in water.
•Do not disassemble or deform the battery
•Do not expose to, or dispose of the battery in fire.
•Avoid excessive physical shock or vibration.
•Keep out of the reach of children.
•Never use a battery that appears to have suffered abuse.
Charge & Discharge
•Before first use battery must be calibrated
•Never use a modified or damaged charger.
•Specified product use only.
•Extra-long battery staying on the charger is not
recommended
Storage
•Store in dark, cool, dry and well-ventilated area.
•Store away from small metal objects that could shot
circuit the battery
Operation
If there is not enough battery capacity for 30minutes of
work software will reject starting new donation

When unpacking the device for the first time user must take additional
care of the battery. Battery manufacturing date is placed on the back
side of the battery year/month/day. Batteries are transported at around
50% charge to achieve safe transport. Before starting the use of the
batteries they need to be recalibrated and charged for the first time.
Remove personal metal items (e.g. metal coins and needles) during the
battery handling procedure. A short circuit through one of these items
can damage the battery.
Depending of planned usage of the battery (how many donations can be
expected in forthcoming day, number of donors, etc.), user should plan
the charging process. Battery can be charged from “zero” or can be re-
charged from some level.

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Calibration Procedure

1. Put battery in battery charger/calibrator


2. Press button for battery calibration (signal blue light is blinking)
3. Calibration cycle should last between 7-8 hours depending of
initial battery status
4. Signal blue light on charger is continuously blue (calibration is
finished)
5. Battery is ready for use

If the device is working on power adapter and the battery is inside, if


there is any power outage device will keep on working on battery and
prevent losing any data. Battery cannot be overcharged in any of
bellowed explained charging procedure.

Charging

Battery charging can be done on 3 ways:


1. While battery is inside of the device, and device is outside of the
Transportation case. Charging is performed over power adapter
plugged to Bagmatic Novo LS. Device is usable during charging.
Expected charging time is 4-6 hours for empty batter.
2. While battery is inside of the device, and device is inside of the
Transportation case. Charging is performed while Transportation
case is closed and power plug is connected to it.
3. Battery charged outside of the device using external charger
single or multi.

Charging procedure with external battery charger

1. Place the charger on a flat level surface and away from sources of
heat and moisture
2. Plug the DC connector from the power supply into the back of the
charger and connect the power supply to the AC main supply
using the cable supplied
3. Place the battery into the battery bay ensuring that the 5-way
connector is fully seated. The LEDs in the status window of the
charger will provide charging information and process will begin
automatically
4. During the charging process the most significant segment is
blinking (the one which is charged)
5. The status of the LEDs can be:
* Green flashing: Battery charging (expected time: 3-4h)
● Green solid: Battery fully charged
* Blue flashing: Battery in calibration mode (expected time: 7-8h)
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● Blue solid: Battery calibrated


* Red flashing: Battery needs re-calibration
● Red solid: Error
6. After the charging/ calibrating process is finished, battery should
be taken out from the charger. Extra-long battery staying on the
charger is not recommended

Battery charger has smart auto recalibration option, in case during


charging it recognizes that the battery is recalibrated. Recalibration will
be started automatically. Guaranteed number of charging cycles is 300
with 90% of capacity and 600 after capacity 70%.
Battery has integrated capacity indicator.

Charging procedure with internal battery charger, inside or


outside of the transportation case

For the internal battery charging procedure there is no difference if the


device is inside of the case or outside of the case. Power supply/charger
must be plugged in Bagmatic Novo LS in both situations. For transport
case, cable is then guided through the special designed cable guiding
hole.

Please respect following procedure:


1. Place the charger on a flat level surface and away from sources of
heat and moisture
2. Make sure that DC plug connector from the charger is plugged
into the device, and connect other side of charger to the AC main
supply
3. Battery starts charging immediately, and if the device is turned
ON there will be indication on the screen that charging is in
progress

Sleeping mode

Sleeping time can be set from 5 to 60 minutes (with 5 minutes step).


After set period of time if device is in main menu, and not used, device
will turn off automatically. In case time is set on 0 (zero), sleeping mode
is disabled. This feature is useful for battery saving, and if the device is
in mobile condition and working on battery, this is a must (as
recommendation set value is 15 minutes).

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9 Bagmatic Novo LS System

Bagmatic Novo LS is a donation mixing scale device equipped with data


storage and communication possibilities. Depending on a model and
configuration USB single or multi point connection and wireless RF
transfer of data are possible. Data transfer can be achieved after each
donation or on the end of collection on site. Also during donation it is
possible to get live view data, check section 10.3 BN data.
To be able to use data collected by the devices a special application
package should be install on a standard PC. PC platform should provide
at minimum 1GB of HDD space, 2GB RAM and dual core CPU. As an
additional hardware a special wireless module is used over standard USB
port.
Currently support is available for Win 7, Win 8.0, Win 8.1, Win10 both
x32 and x64 architectures.
Installation is distributed on application DVD which contains MySQL
server, application and configuration packages as well as additional tools
and drivers for wireless module for all supported OS-s.

Installation DVD

Installation process is very simple and involves running DVD auto-run


option automatically or manually depending on your security settings.
Administration rights are only needed during installation.

Auto-run will inspect your system and detect OS version and architecture
and open correspondent install shield.

Installation shield
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Depending on information system used in your installation place two


types of installation can be selected. If no integration with blood bank
information system is needed or for any reason Bagmatics should form
an individual system it is needed to install first MySQL server and later to
configure its usage. If integration with BBIS is needed it is still good to
use MySQL server installation for local reporting and workflow checks,
but it is not mandatory. This also depends on the selected method of
system integration. Software offers direct TCP/IP integration, DB Linking
or simple file export transfer.
Upon each selected install methods please follow on screen instructions
that will guide thru the complete process.

When system is installed your package should consists of four basic


modules. Additional modules can also be available depending on your
order configuration or specific customization.

Basic modules symbols

Basic modules are:


1. BNS (Bagmatic Novo LS Service control) - Core application for
communication service control.
2. BN_Setup (Setup and configuration tool) – Application for device
service, configuration and maintenance
3. BN_Live (Donation real time process monitor) – Application for
remotely tracking donation status graphically
4. BN_Data (Donation local data management module) - Independent
application for data processing, reporting, analyse and data back up

For system normal operation BNS module has to be active all the time.
Since the structure of ERYSYS system is module based same installation
can be performed on any number of PCs giving a possibility of remote
access and tracking of donation rooms from a single point in system or
from multiple locations.
Linking with BBIS is possible in two ways: Local or Remote. In Local
configuration ERYSYS package will not deliver Transferring module and
will need local installation of BBIS to transfer information. If a remote
linking is used a Transferring module installation will be given separately
depending on network configuration. In this mode only BNS is needed in
each local site. Other modules and MySQL server should be installed only
on central location.
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Local Linking architecture

Remote Linking architecture

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9.1 Erysys Start-up and adjustment

After successful installation a core service has to be set and started in


order for all other modules to work. If a wireless communication is to be
used wireless module should plugged-in to USB and recognized by
operating system. If any problems exist please search installation DVD
for drivers and perform manual installation.
After successfully installation of wireless module please run BNS module
from ERYSYS program group in start menu. If module is not detected a
message will be shown with “ERROR CODE=1” indicating a problem in
connecting wireless module. If this is the situation please check module
installation in device manager. In an event of successful service start up
an ERYSYS logo screen with version will be shown and access to the
service setup will be provided thru system try icon.

Successful service start up screen

Last step to a system start up should be to adjust parameters for


modules intercommunication and BBIS link method. In order to perform
this please use menu from system try BNS icon and select “Setup”.

BNS Control menu

Setup option will open new dialog divided into three sections: General,
Database and Advanced. On general tab basic communication
parameters can be set as well as an automatic start up option that is
useful if equipment is turning off at working day end.

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Second tab offers database connection parameters and an option to


decide if collected data will be stored in database or not. Database can
be installed on the same PC or over the network and different databases
can be used if needed.

BNS Standard settings

Third set of advanced options are related to BBIS integration and depend
on architecture selection and installation. Export Data can be differently
setup and changed accordingly requirement of the BBIS. One example is
simple file connection in which a setup for delimiters (like TAB, comma,
semicolon…) and fields (length, start, stop codes…) are available. Data
can be exported in single file or in one file per working day with flexible
selection on fields order and contents.

It is possible to choose Delimiter for the data file, for Column, Date and
Time. If you leave it blank, data will be without any delimiter. To go to
Column order press corresponding button on same tab.

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Which data should be exported can be selected from the list on left side.
Data arrangement for export if made on the right side of the setup. See
example on the pictures below.
Time format is HHMMSS with selected delimiter between
Date format is DDMMYYYY with selected delimiter between.

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Advanced Settings – Columns selection

If one per day export file is selected file name will be formed like:
“Export_23_01_2013.txt” where “Export” and “txt” can be changed in a
different format like .csv type.

Export file example in txt.


Date Time Vol Duration Donor ID Donation ID Operator ID Device ID

08092014;152604;480;0522;5769304111;72142011243;PNCR;BN1131232

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After any setup changes a BNS restart is advisable. In most cases


system will perform this automatically but also a manual option is given
in BNS control menu.
BNS keeps track of all devices in the range constantly. Status is
refreshed on each 5 seconds or longer depending on devices current
tasks. If at any time a manual update is needed BNS control menu offers
“Scan” function. Device status can be monitored constantly in a pop-up
window accessible by moving your mouse pointer to the most right side
of screen. Each device is represented by Bagmatic Novo LS icon and
serial number with two colour boxes indicators. If both indicators are red
device is not available on the network. If first indicator is green and
second is red data transfer is in progress. If both indicators are green
device is available for operation and all data are transferred.

Status monitor window

9.2 BN_Setup Tool

BN_Setup module is intended when device maintenance and installation


or reconfiguration is to take place. For this tool to operate a BNS has to
be operational. This tool can be run on the same PC where BNS is
installed or on any local network PC which is used for maintenance. In
such way a remote support can be easily implemented.
To use the tool a password is needed in order of prevention of none
authorize access. Default password is “1234” but it is strongly suggested
to change it after first installation. For this and other tool settings please
use settings menu from main BN_Setup toolbar.

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BN_Setup tool access rights

If a BNS is detected and running after login on bottom status bar in a left
corner message “Connected” should appear. If this is not the case please
check BNS and BN_Setup parameters to match and BNS in running mode
and try to establish connection by manual connect function from
BN_Setup Toolbar.
If a connection is working a list of available devices are shown on left
side of main working window. To refresh this list a Re-scan function is
given next to connect command on toolbar.
To access any given device and load complete device settings just select
device with right serial number from the list. A separate window will
open loading data. After some seconds complete configuration is
transferred. Only one device can be set or read at given time due to
security encryption of data transfer.

IMPORTANT:
Main menu of device must be able to access for parameter readout and
changes. If not an indication of device in use will be shown after
timeout.

Devices parameters can be easily change thru simple Property Grid


controls divided into sections. Each option has its short explanation and
predefined values checking. Side menu serves like additional set of
actions that can be perform but only for the selected device. This menu
offers Reading configuration, writing changes exporting configuration to
a file and importing already saved configuration.

Apart basic reading-writing configuration BN_Setup offers same


configuration setup for all devices detected on the network. To activate
this option it is best to first read one of devices configuration, then make

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all needed changes and save it to a file. After this select “Set All Devices”
from toolbar and load saved file. Now the system is ready and a write
command from left toolbar can be used. Successfulness of writing
process could be tracked on the indication list with all devices present in
the system.
This operation writes all the settings to each device so be patient and
wait for a confirmation message that process is finished.
It is also possible to set only a subset of devices while other devices are
busy with donation or just not at main menu.

BN Setup explanation
BN Setup – General tab

General tab allows to change General parameters for Bagmatic Novo.


Each parameter is responsible for certain behaviour of the device, like
reaction of the device in certain situation. Example of parameter are:

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rotation speeds, density of the whole blood, min and max flow, interrupt
time, different alarms…
BN setup – Process tab

Process tab allows different Audio signals change, different control of


data, illumination signal control, check length…

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BN setup – barcodes

Third tab is a barcode setup, for every barcode it is possible to choose


options like, if it is turned ON, maximum length (max 25 characters),
minimum length (min 0 characters), Start code, Stop code. In that way
every barcode can be defined and checked by its characteristic option
and cannot be mixed with any another.

Serial number change procedure

If for any reason a serial number of the device needs to be changed “Set
SN” function from main toolbar should be used. Because this is dangers
operation and no to devices with same SN should exist in one system an
additional password protection is introduced. Only with master password
which is not changeable a new serial number can be added. After serial
number modification a rescan option should be used to invalidate device
list.

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Serial number modification

9.3 BN_Live

During donation it is possible to monitor donation process graphically for


all devices. Monitoring can be done remotely as long as a link to PC
running BNS exists. BN_Live module is used for donation real time
tracking. Application has a simple connection interface to BNS and a list
of available devices shown in the same way as in setup tool. Refreshing
is done on each of 5 seconds for all donations. Graph shows both weight
and flow data. In addition with remote alarming module errors can be
sent directly to nurses phone or any other mobile device that has
network access.

Donation Live tracking

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9.4 BN_Data Center

If installed My SQL database can store locally all donation data. For
simple data management as a standard module Data Center is shipped
with each ERYSYS configuration. This is a standalone application that can
work on any part of the network as long as it has access to a database
server PC. At the start up application will ask for a connection setting.
Once good connection to database is established a main window will be
shown.

Main DB settings

In basic configuration Data Center provides donations analysis and


compare. Filtered search for a specific set of donations. Printing reports
with variable parameters and manual data export. Access to all options is
organized in as simple control ribbon at the application top. As an
addition to this in specific places a shortcut to speed up work is also
provided.

Control Ribbon

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Under data section an access to donation information is given through


searching for a donation with given donation ID, list of donation finish
today or full scale search. By selecting any of donation a detail view will
be opened.

Today list

Search Filter
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Data Centre offers simple report template that can be customize upon
customer request and which has configurable setup. Full printing support
is integrated including the document viewer.

Printing centre

Basic report example

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Like BNS data centar can generate any format of export file. Data can be
manually exported and imported into standard MS Excel or other CSV file
editors or printed separately.

Export setup

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10 RF range limitations

Achieved range with external RF module is up to 55 m in free space.


Free space means open field space, free of physical obstacles between
the transmitter and receiver, without electromagnetic influence from
other sources, and with optical visibility in between.

Any obstacles or other RF signal sources in same frequency range could


cause interference and significantly diminish communication range.

Note: Wireless range can be decreased in case of


interference with other signals at same frequency and in
case of obstacles.
To achieve maximal range (no obstacles or interference
should be allowed).

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11 Maintenance

Note: Preliminary inspections have to be done on annual bases.


Only certified specialist can carry out any maintenance or
service on the Bagmatic. Not trained personal must attend
the service training first.

11.1 Maintenance schedule

SCHEDULE
Component Suggested action
wee mon yea
advice
kly thly rly
Every month or
more often
As per section 5.2.
depends on
Clean it as suggested
Device usage of
in table or in case of X  X
cleaning device, when
blood stains
notice it is
immediately.
dirty.
(mandatory)
Calibration
should be done
once per year
by authorized
Calibrate balance person for
Calibration of
when schedule is X X  stationary use.
balance
reached. For mobile use
it is
recommended
daily calibration
(mandatory)
Complete
device setting
Perform complete
and service
Periodic checking of the device
must be done
preventive using official test X X 
by authorized
maintenance protocol, and check
person.
mechanical parts.
(recommended
)

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12.2 Periodic Preventive maintenance

Balance insurance check


1 Check balance insurance, with 4kg load gap should be 0.1-0.05mm. Upper
protection is 0.2-0.3mm
Belt tighten
2
Check if belt is not lose or tight too much
Connectors and cables check
3
Visual inspection of cables and connectors
Overall look of the device and screws position
4 Check if there are some visual damages on device and check if screws are
secured well
3D mechanism check, motor speed check
5 Check if motor noise is constant and if there are no bump vibrations on
housing. Check motor speed on adapter and battery
Check if Battery is holding voltage
6 Put the battery in and check if battery parameters are indicated on display.
No voltage drop seen on display
Calibration 500gr + check
7
Calibrate and check weight measuring of the device
AD values for 0gr, 500gr and max AD (4095)
8
Check weight as in the table and write corresponding AD values
Clamp calibration check (with bag with wather)
9 Check if Clamp is closing and opening.
In closed position, liquid (water) must not pass through the tube
Tube sensor check
10 Tube detection test from service menu. Moving tube to left and right side to
check if the micro switch is jamming
Time settings check (with reset)
11
Check time settings, reset the device and check again.
Donation simulation + Data transfer check (rf/usb)
12 Perform an simulation with water, measure final weight and compare with
set weight

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12 Troubleshooting

12.1 Balance failed


If during initialization process device appear this message, please check
tray. Tray must be free, without any things on it. Then turn on device
again. If device again appear same message, call service.
0x01 – Time exceeded for taking zero on the balance
0x02 – AD value is out of the defined boundaries

Advice:
If device shows this message with some of codes, which mention above,
please turn off device and again turn on it. If device again appear this
message please contact technical support.

12.2 Battery error


Battery error codes:
0x01 – Battery initialization needed
0x02 – Battery recalibration needed
0x03 – Battery recalibration and initialization needed
0x04 – Communication error and battery initialization needed
0x05 – Communication error and battery recalibration and initialization
needed

Battery error code will be displayed on the screen.

Advice:
If device shows this message with some of codes, which mention above,
please turn off device and again turn on it. If device again appear this
message please contact technical support.

12.3 RTC error


0x01 – Time not working
0x02 – Date not working
0xF3 – RTC chip writing not possible
0xFF – No communication with RTC chip in 10 tries

Advice:
If device shows this message with some of codes, which mention above,
please turn off device and again turn on it. If device again appear this
message please contact technical support.

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12.4 Clamp error


0x01 – Magnetic sensor for positioning the tray is not working

Advice:
If device shows this message with some of codes, which mention above,
please turn off device and again turn on it. If device again appear this
message please contact technical support.

12.5 EEPROM
0x01 – If write in EEPROM during initialization is not working.

Advice:
If device shows this message with some of codes, which mention above,
please turn off device and again turn on it. If device again appear this
message please contact technical support.

12.6 Wrong weight on tray and missing tube in the clamp

If weight on the tray at start donation process is wrong or tube is not


placed correctly, error will appear on screen.

Advice:
Please check if bag system is placed correctly that bag is not touching
the housing. If bag system is placed correctly, please turn OFF the
device, remove all bags and obstacles from the bag tray and Turn ON
Bagmatic Novo LS again. Make sure that correct starting procedure is
performed.

Go to Balance selection from the Main menu, see section 8.2 Balance
selection, without any weight it should display “0g” and if you put 500g it
should measure approx. 500g. If these two values are correct, try to
start donation. If you have again same error, please contact technical
support.

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12.7 Over weight error

Picture below shows over weight error. This means that if flow is much
greater than defined and it lasts longer than 3 seconds, device will show
this error.

Advice:

User should check tray and bugs system in case there was accidental
touch or fall of some object.
After correction please press “Menu” button to continue. Device will
check tray, and if weight is in allowed range, donation will be continued.
If weight on tray is in allowed range, but device shows this message,
please contact technical support.

12.8 Pause
During Donation it is possible to Pause the donation to perform labelling
or some other reason. In this case device will note this condition as
interrupt time error, and automatic restart of PAUSE will initiate after
some period of time predefined by parameter. Manually user can
CONTINUE, and donation process will be continued. Otherwise, if user
presses button STOP, donation process will be stopped.

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12.9 Stop

During Donation it is possible to STOP the donation. User can decide if he


wants to Cancel totally or to Continue again.
Cancelling will require confirmation one more time to STOP the
extraction.

13 Explanation of Symbols

Caution information

Notes information

European Union WEEE Directive Logo


according to Waste Electrical and Electronic
Equipment Directive 2002/96/EC

The system has CE mark.


0123 0123 = number of Notified Body

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14 Spare parts

Item code Item Note


PCB Bagmatic Novo
1 BA-30311
LSMainboard
Touch screen Display
2 NO-10005
Bagmatic Novo
PCB Bagmatic Novo
3 BA-30028
LSbackboard
4 BA-30029 Clamp regulator
PCB USB Bagmatic Novo
5 BA-30017
Communication board
6 BA-30018 RF module

7 BA-30031 Illumination ring

8 BA-30032 PCB Hall Sensor + Carrier

9 BA-30033 Spring 9x33x1,25 BN

10 BA-30013 3D shake Motor with gearbox

11 BA-30010 Clamp Motor with gearbox

12 BA-30310 Housing (Top cover)

13 BA-30036 Housing (Bottom cover)

14 BA-30037 Moving plate

15 BA-30038 Aluminium Cap

16 BA-30039 3D Shake Motor holder

17 BA-30040 Illumination ring holder BN

18 BA-30041 Plexiglas Illumination ring

19 BA-30042 Small Pulley

20 BA-30043 Tube press holder

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Slider BN (in Clamp


21 BA-30044
assembly)
22 BA-30045 Central slider

23 BA-30046 Clamp body BN

24 BA-30047 Housing for bearings

25 BA-30048 Big Pulley

26 BA-30049 Aluminium Tube holder

27 BA-30050 Aluminium Cap holder


Battery charger Bagmatic
28 BA-30015
Novo
29 BA-30014 Battery Bagmatic Novo

30 BA-30022 USB Wireless Data Module

31 BA-30020 Bagmatic Novo LSCase


Power Supply/battery
32 BA-30312
charger Bagmatic Novo
Keyboard Mask Bagmatic
33 BA-30051
Novo
34 BA-10047 Load cell

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15 Alert list

Alert When Audio Visual Adjustable

1 Initialization Starting device No Yes Yes


Near donation During donation
2 Yes Yes Yes
end process
Interrupt during
During donation
3 donation Yes Yes Yes
process
process/ Pause
During donation
4 Overweight Yes Yes Yes
process
Correct end of End of donation
5 Yes Yes Yes
donation process
Not correct end End of donation
6 Yes Yes Yes
of donation process
Unexpected
Donation start
7 weight on Yes Yes Yes
donation start
8 User stop Donation process Yes Yes Yes
Interrupt time
9 Donation process Yes Yes Yes
out
Motor is going to
10 Wait for motor No Yes Yes
start position
Donation start
Start donation
without tube in
11 process without Yes Yes Yes
clamp
tube in clamp

12 Self-test error After self-test Yes No Yes

Tube error
During donation
13 during donation Yes Yes Yes
process
process
Flow alarm: During donation
14 Yes Yes Yes
High/Low process
Maximum During donation
15 Yes Yes Yes
overtime process
Barcode reading During donation
16 Yes Yes Yes
error process

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